Serious Adverse Event (SAE)

Report Form

STUDY NAME

Protocol Number: Date Participant Reported:

Site Name: / / .
d d m m m y y y y
Pt ID:

1. SAE onset date: ___ ___ / ___ ___ ___ / ___ ___ ___ ___
d d m m m y y y y

2. SAE stop date: ___ ___ / ___ ___ ___ / ___ ___ ___ ___
d d m m m y y y y

3. Location of SAE:

4. Was this an unexpected adverse event? Yes No

5. Brief description of participants with no personal identifiers:

Sex: F M Age:
Diagnosis for study participation:

6. Brief description of the nature of the SAE (attach description if more space is needed):

7. Category of the SAE:

Date of death ___/_____/_______ Congenital anomaly/birth defect
(dd/mmm/yyyy) Required intervention to prevent permanent
Life threatening impairment
Hospitalization – initial or prolonged Other:
Disability/incapacity

8. Intervention type:
Medication or nutritional supplement (specify):
Device (specify):
Surgery (specify):
Behavioral/lifestyle (specify):
9. Relationship of event to intervention:
Unrelated (clearly not related to the intervention)
Possible (may be related to intervention)
Definite (clearly related to intervention)

10. Was study intervention discontinued due to event? Yes No

11. What medications or other steps were taken to treat the SAE?

12. List any relevant tests, laboratory data, and history, including preexisting medical conditions:

13. Type of report:

Initial
Follow-up
Final

Signature of principal investigator: _______________________________ Date: __________________